E-cigarette Makers Fail to Win Exemption from FDA Regulation

E-cigarette makers failed to get a grandfather clause inserted in the omnibus spending bill that would have exempted certain products from being regulated by the U.S. Food and Drug Administration (FDA).

The exemption was one of a number of policy riders considered for the House’s fiscal 2016 spending bill, and it would have given an exemption to e-cigarettes already on the market before the FDA finalizes its proposed rules, Modern Healthcare reports.The FDA released proposed e-cigarette regulations in April 2014 but has delayed making them final amid significant objections from both critics and proponents of e-cigarettes. The draft regulations would require any e-cigarettes made after February 2007 to get FDA approval before they can be sold.

The final FDA regulations are under review by the White House Office of Management and Budget and are expected to be released sometime next year, according to Modern Healthcare.

The American Vaping Association, an industry trade group, said the decision is like a modern-day “prohibition” of the devices and will harm public health, Modern Healthcare writes. Gregory Conley, president of the American Vaping Association, said, “This deal protects cigarette markets.” Conley said Congress “squandered a real opportunity to benefit both public health and small businesses across the country.”

Under the FDA’s draft rules, e-cigarettes could not be sold to anyone under the age of 18 and manufacturers would be required to include health warnings telling users that nicotine is addictive. Manufacturers would also be required to disclose their ingredients to the FDA and would not be allowed to make any claims that say their products are safer than tobacco products.

The debate over e-cigarettes centers on the claims that the devices are a less harmful alternative to traditional tobacco products. But electronic cigarettes have come under increased scrutiny as their popularity has grown. Public health officials like the Centers for Disease Control and Prevention (CDC) are alarmed by the increased use of e-cigarettes among teenagers. Some health officials are concerned that e-cigarettes are a gateway to use of traditional tobacco products.

Recent research indicates that e-cigarettes are not as safe as the industry claims. Some of the candy-flavored liquids used in e-cigarettes contain chemicals that cause bronchiolitis obliterans, a serious, irreversible lung disease. In addition, young children can suffer serious, even fatal, nicotine poisoning if they swallow e-cigarette liquid. The liquids with fruit and candy flavors can be very appealing to young children and, at present, are not required to be packaged with childproof caps.

There have also been a number of reports of injuries from e-cigarette explosions or battery fires. In one such incident, a Florida man was critically injured when an e-cigarette exploded in his face. Evan Spahlinger suffered internal and external burns and damage to his lungs and he was put into a medically induced coma to ease his pain. Other users have suffered burns and injuries to fingers, lips, and faces, and e-cigarettes have been responsible for starting fires that have caused property damage.